| 1 | 25- Donor Suitability Assessment | - The establishment did not perform some donor testing as required for the regular process.
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| 2 | 34- Directed Donation Process | - The establishment did not perform some donor testing as required for the directed donation process.
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| 3 | 23- Donor Suitability Assessment | - The establishment did not always perform donor screening in accordance with the requirements set out in the Directive.
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| 4 | 25- Donor Suitability Assessment | - The establishment did not perform some donor testing as required for the regular process.
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| 5 | 27- Donor Suitability Assessment | - The summary document confirming the donor suitability did not always include some required information.
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| 6 | 32- Directed Donation Process | - The establishment did not always perform donor screening for directed donors in accordance with the requirements set out in the Directive.
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| 7 | 34- Directed Donation Process | - The establishment did not perform some donor testing as required for the directed donation process.
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| 8 | 36- Directed Donation Process | - The summary document confirming the directed donation did not always include all required information.
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| 9 | 40- Directed Donation Process | - The communication of risk, in the context of a directed donation, was not sufficient.
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| 10 | 43- Quality Management System | - The establishment’s document control or records management system was not sufficient.
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| 11 | 45- Quality Management System | - The establishment did not carry out an internal audit every two years of the activities that it conducts to ensure that the activities comply with the Regulations and with its standard operating procedures.
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| 12 | 57- Personnel, Facilities, Equipment and Supplies | - The establishment did not ensure that some critical equipment was validated, calibrated, cleaned or maintained as required.
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| 13 | 80- Records | - The establishment records of importation and/or distribution did not include all required information.
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| 14 | 23- Donor Suitability Assessment | - The establishment’s structured donor screening questionnaire(s) did not include some criteria outlined in the Directive.
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| 15 | 24- Donor Suitability Assessment | - The establishment did not perform the physical examination in accordance with the requirements set out in the Directive.
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| 16 | 27- Donor Suitability Assessment | - The medical director did not always create and sign a summary document to confirm the donor suitability.
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| 17 | 32- Directed Donation Process | - The establishment’s structured donor screening questionnaire for directed donors did not include some criteria outlined in the directive.
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| 18 | 33- Directed Donation Process | - The establishment did not perform a physical exam on the directed donors in accordance with the Directive.
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| 19 | 36- Directed Donation Process | - The primary establishment did not always ensure that the medical director created or signed a summary document for directed donations.
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| 20 | 44- Quality Management System | - Some processes were not described in standard operating procedures.
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| 21 | 44- Quality Management System | - Some standard operating procedures were not kept up to date.
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| 22 | 53- Personnel, Facilities, Equipment and Supplies | - The establishment’s program for the initial and ongoing training of some personnel and for evaluating their competency was not sufficient.
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| 23 | 58- Personnel, Facilities, Equipment and Supplies | - Critical supplies were not validated or qualified as applicable for their intended use.
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| 24 | 59- Errors and Accidents | - The establishment did not establish and maintain a system that allows for the identification, investigation and reporting of all error and accidents.
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| 25 | 69- Adverse Reactions | - The establishment did not establish and maintain a system that allows for the identification, investigation and reporting of all adverse reactions.
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| 26 | 84- Records | - The establishment’s records were not always accurate, complete, legible and/or indelible.
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